The FDA has granted 510(k) clearance to AI Optics’ Sentinel Camera, a handheld retinal imaging system that captures ...

RapidAI announced that it received FDA 510(k) clearance for its Lumina 3D automated 3D imaging reconstruction solution.

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life ...

Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading on policies involving artificial ...

New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain ...

The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.

More than 10 million babies have been born through IVF, yet the process is still invasive and costly. Plus, why a venture ...

Results from the study assisted Notal Vision in receiving De Novo authorization from the US FDA for the SCANLY Home OCT in ...

Modella AI, a pioneer in generative and agentic artificial intelligence for biomedicine, is proud to announce that its ...

The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to ...

We recently published a list of 10 AI News and Ratings Too Important to Miss. In this article, we are going to take a look at where GE HealthCare Technologies Inc.

Tempus AI's innovative products are transforming the healthcare industry, with a focus on oncology and large market ...